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Specification:
Test | Test |
| Test | Standard | results |
items | methods | unit | results | ||
Apearance | USP | / | Pass | White crystal | Conform |
Identification by FTIR | USP-EP | / | Pass | Pass | Conform |
Color of solution | USP | / | Pass | Pass | Conform |
Clarity of solution | USP | / | Pass | Pass | Conform |
Assay | USP-EP | % | 99.44 | 99-101 | Conform |
(on anhydrous basis) | |||||
Water | USP-EP | % | 14.06 | ≤15 | Conform |
Acidity or | USP-EP | / | Pass | Pass | Conform |
alkalinity | |||||
o-Toluenesulphonamides | USP-EP | mg/kg | Pass | Pass | Conform |
p-Toluenesulphonamides | USP-EP | mg/kg | Pass | Pass |
|
Heavy metals | USP | mg/kg | <10 | ≤10 | Conform |
Benzoate and | USP | / | Pass | Pass | Conform |
salicylate | |||||
Readily | USP-EP | / | Pass | Pass | Conform |
carbonizable | |||||
substances | |||||
Organic | USP | / | Pass | Pass | Conform |
volatile | |||||
impurities | |||||
Aerobic plate count | QMIC-0002 | cfu/g |
| <10 | Conform |
Yeasts and fungi (Molds) | QMIC-0002 | cfu/g |
| <10 | Conform |
Gram Negative Bacilli | QMIC-0002 | cfu/g |
| <10 | Conform |
Staphlococcus aureus | QMIC-0002 | cfu/g |
| 0 | Conform |
Saccharin Sodium 20-40mesh
Saccharin Sodium 20-40mesh
